Elective Induction vs Spontaneous Labour in Patients With Heart Disease

NCT01677364 | Completed

• 1 other identifier: 7862/PG/2Trg/08
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Fifty pregnant patients with acquired and congenital heart disease between 38-41 weeks were randomised into elective induction and spontaneous labour groups only after bishop score was equal to or more than 6.It was concluded that induction of labour with oxytocin is a relatively safe procedure in women with low risk heart disease with NYHA class I and II. It resulted in a similar caesarean delivery rate and was not associated with more maternal and neonatal complications.

Conditions

Heart; Disease,Complicating Pregnancy, Pre-existing

Keywords

induction of labour; heart disease patients

Outcome Measures

Primary Outcomes (3)

• Duration of labour

  at the time of delivery

• Rate of caesarean section

  mode of delivery and rate of caesarean section with indication

  at the time of delivery

• Number of patients with delivery during workday hours

  at the time of delivery

Secondary Outcomes (2)

• number of patients with maternal complications

  day 5

• number of patients with adverse neonatal outcome

  day 5

Study Arms (2)

induction of labour

ACTIVE COMPARATOR

drug- infusion of 30U oxytocin diluted in 500ml normal saline given at rate of 3mU/min and subsequently dose increased 3mU/min every 45 min

Drug: Oxytocin

Spontaneous Labour

NO INTERVENTION

patients were allowed to go into spontaneous labour

Interventions

Oxytocin DRUG

Arm - Induction of labour

induction of labour

Eligibility Criteria

• Age: 19 Years - 37 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• NYHA class I-II
• cephalic presentation
• singleton gestation

You may not qualify if:

• previous cesarean section,
• Primary pulmonary hypertension,
• Eisenmenger syndrome,
• Marfan syndrome,
• Left heart obstruction,
• Prior cardiac event or arrhythmia,
• Malformed fetus,
• Severe anemia (\<7g/dl),
• Intrauterine fetal death,
• other obstetrical indications for induction of labour
• patients on anticoagulation.

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Post Graduate Institute of Medical Education and Research

Chandigarh, Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Disease; Pregnancy Complications

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.Yogita Dogra

Study Record Dates

• First Submitted: August 26, 2012
• First Posted: September 3, 2012
• Study Start: July 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: September 3, 2012

Record last verified: 2012-08

Locations

IN (1)